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Clean room GMP workshop

Industrial modular Clean Room time:2022/03/21 09:40:35 click:285

Clean Room (Workshop)

Clean Room, also known as dust-free workshop, dust-free Room or Clean Room, refers to the elimination of particles, harmful air, bacteria and other pollutants in the air within a certain space range, and the indoor temperature, cleanliness, indoor pressure, airflow speed and airflow distribution, noise and vibration and lighting, static electricity control within a certain demand range. And given specially designed rooms.
Clean room GMP workshop

GMP workshop

GMP is a mandatory national standard applicable to the pharmaceutical and food industries. Workshops built according to clean room standards in relevant industries and in line with the requirements of GMP quality and safety management system are called GMP workshops.

Industrial clean rooms are designed for the control of inanimate particles. It mainly controls the pollution of air dust particles to work objects, and generally maintains positive pressure inside. It is suitable for precision machinery industry, electronic industry (semiconductor, integrated circuit, etc.) aerospace industry, high purity chemical industry, atomic energy industry, optical magnetic products industry (CD, film, tape production)LCD(liquid crystal glass), computer hard disk, computer magnetic head production and other industries.

Biological clean room mainly controls the pollution of working objects by living particles (bacteria) and inanimate particles (dust).

General biological clean room:

It mainly controls contamination of microbial (bacterial) objects. At the same time, its internal materials should be able to withstand the erosion of various sterilizers, and the internal pressure is generally guaranteed.

Biological safety clean room:

The main object of control is the pollution of living particles to the outside world and people. The interior should maintain negative pressure with the atmosphere. Examples: bacteriology, biology, clean laboratory, physical engineering (recombinant gene, vaccine preparation).

Table of air cleanliness of clean room (area)

Maximum allowable number of dust particles per cubic meter of cleanliness

(static) Maximum number of microorganisms allowed

(static) ventilation times ≥0.5μm≥5μm Plankton/m3 sedimentation bacteria / ф 90 dish 0.5H100 class 3500050.5 Note 210000 class 01.5≥20 times/hour 100000 class 01503≥15 times/hour 300000 class 002005≥10 times/hou

Clean room functional area division: generally divided into three areas, clean area, quasi-clean area and auxiliary area.

Main purification equipment: air shower room, cargo shower room, transfer window, efficient air outlet, laminar flow cover (FFU), clean table and other purification equipment.

Decoration part: decoration materials require no dust, no dust, easy to clean, smooth surface with wear resistance, good insulation performance, not easy to produce static electricity, no moisture, moisture permeability, sound absorption performance is good. Generally, color steel plate is used for enclosing part to ensure sealing performance, and the ground is self-leveling with epoxy resin.

Purification principle:

Air flow → primary effect air treatment → air conditioning → medium effect air treatment → fan pressurized air supply → purification air supply pipe → high efficiency air supply outlet → clean room → dust (bacteria)→ return air alley → fresh air and primary effect air treatment. Repeat the above process, can achieve the purpose of purification.

Pressure difference control: the pressure difference between clean rooms of different cleanliness levels is not less than 5Pa, and the area with higher cleanliness levels is positive pressure; The pressure difference between clean area and non-clean area should be maintained at least 5Pa, and the pressure difference between clean area and outdoor should be maintained at least 10Pa.